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The efficacy and safety of ivabradine hydrochloride versus atenolol in Chinese patients with chronic stable angina pectoris

Authors

  • Yan Li,

    1. Center of Clinical Pharmacology, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, State Key Laboratory of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Linde Jing,

    1. Department of Cardiology, Qinghai Province People's Hospital, Xining, Qinghai Province, China
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  • Yishi Li,

    1. Center of Clinical Pharmacology, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, State Key Laboratory of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Jinfa Jiang,

    1. Department of Cardiology, Tongji Hospital Affiliated to Tongji University, Shanghai, China
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  • Zhirong Wang,

    1. Department of Cardiology, Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu Province, China
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  • Jin Wei,

    1. Department of Cardiology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi Province, China
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  • Xingtao Li,

    1. Department of Cardiology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China
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  • Lin Wang,

    1. Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China
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  • Hao Xia,

    1. Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China
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  • Tianfa Li,

    1. Department of Cardiology, Affiliated Hospital of Hainan Medical College, Haikou, Hainan Province, China
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  • Shaowen Liu,

    1. Department of Cardiology, Shanghai First People's Hospital, Shanghai, China
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  • Bo Xing,

    1. Department of Cardiology, Haikou People's Hospital, Haikou, Hainan Province, China
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  • Zhenyu Yang,

    1. Department of Cardiology, Wuxi People's Hospital, Wuxi, Jiangsu Province, China
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  • Qinghua Lu,

    1. Department of Cardiology, Second Hospital of Shandong University, Jinan, Shandong Province, China
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  • Rongjian Jiang,

    1. Department of Cardiology, Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences, Chengdu, Sichuan Province, China
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  • Ping Xie,

    1. Department of Cardiology, Gansu Provincial Hospital, Lanzhou, Gansu Province, China
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  • Xiling Shou,

    1. Department of Cardiology, Shanxi Provincial People's Hospital, Xi'an, Shanxi Province, China
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  • Xiaofeng Wang,

    1. Department of Cardiology, Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region, Urumchi, Xinjiang Province, China
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  • Youhong Jia

    Corresponding author
    1. Center of Clinical Pharmacology, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, State Key Laboratory of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
    • Correspondence to: Y. Jia, Center of Clinical Pharmacology, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, State Key Laboratory of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, China, 100037. Email: yhjia2002@gmail.com

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  • Prior postings and presentations: The abstract was published at 2013 China Heart Congress by Yan Li.

  • A randomized, double-blind, double-dummy, multicenter, active-controlled, non-inferiority clinical trial

ABSTRACT

Purpose

The aim of this study was to assess the efficacy and safety of ivabradine (Iva) noninferiority to atenolol (Aten) in Chinese patients with chronic stable angina pectoris.

Methods

In this double-blind, double-dummy trial, patients with symptomatic angina pectoris and positive exercise tolerance test were randomized into the Iva [5 or 7.5 mg bis in die (BID)] or Aten group (12.5 or 25 mg BID) according to computer-generated random numbers for 12 weeks.

Results

One hundred and sixty-eight patients were randomized to the Iva group and 166 to the Aten group. In a full analysis set, increases in the total exercise duration (TED) were 54.3 ± 120.1 seconds with Iva 5 mg and 58.8 ± 114.7 seconds with Aten 12.5 mg at the fourth week, and at the 12th week, TED improved by 84.1 ± 130.5 seconds with Iva and 77.8 ± 126.6 seconds with Aten (95%CI: −21.4–34.1 seconds, p = 0.0011 for noninferiority). The analysis of per protocol set yielded similar results (95%CI: −31.4–33.0 seconds, p = 0.0131 for noninferiority). Heart rate was reduced in both groups at rest and during peak exercise. There were small, nonsignificant differences in the number of adverse events between the two groups (66 in Iva and 73 in Aten, p > 0.05). Nine patients (5.42%) were reported to develop phosphenes/luminous phenomena and blurred vision in the Iva group (p = 0.0035).

Conclusions

Iva is effective in reducing heart rates and improving exercise capacity and noninferior to Aten in Chinese patients with chronic stable angina pectoris. Iva is well tolerated and safe. Copyright © 2014 John Wiley & Sons, Ltd.

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